This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms.
Primary Endpoints: Safety: Death or stroke in downstream territory to 180-days post-procedure Technical Success: Device placement success and ability to retain coils within the aneurysm (as judged by the treating physician at the time of the procedure. Core lab will review images at a later time) Rate of aneurysm occlusion at Day zero (0) and 180-days Additional Evaluations to 180-days and at 365-day follow up Rate of aneurysm occlusion at 365 days Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, CTA or MRA (180 days) and (365 days) Stenosis defined as \>50% at implant site by conventional catheter angiography, MRA or CTA at 180 days and at 365 days Rate of incidence of new neurological deficits Complication rate (neurological and non-neurological)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Adjunctive device for endovascular embolization of intracranial aneurysms
Paracelsus Medical University Salzburg
Salzburg, Austria
Safety: Death or stroke in downstream territory
Time frame: to 180-days post-procedure
Technical Success
Device placement success and ability to retain coils within the aneurysm
Time frame: at the time of the procedure
Rate of aneurysm occlusion
Time frame: Day zero (within 24 hours post procedure) and 180-days
Rate of aneurysm occlusion
Time frame: at 365-days follow-up
Device movement or migration defined as any relative change in the position of the device with respect to the parent and/or daughter vessels that is greater than 2mm by conventional catheter angiography, MRA or CTA
Time frame: at 180-days follow-up and 365-days follow-up
Stenosis, defined as >50% at implant site by MR angiography or conventional catheter angiography or CTA
Time frame: at 180-days follow-up and 365-days follow-up
Rate of incidence of new neurological deficits
Time frame: from the time of the procedure to the 365-follow up visit
Complication rate (neurological and non-neurological)
Time frame: from the time of the procedure to the 365-follow up visit
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